Allogeneic haematopoietic stem cell transplantation from a matched donor in patients with chronic myeloid leukemia failing to gain normal hemopoiesis under TKIs therapy - NA

IVERSITà DEGLI STUDI MILANO BICOCCA0 个研究点目标入组 20 人开始时间: 2015年5月13日最近更新: 2020年11月3日

适应症

试验速览

暂无简介。

•-1.Chronic Myeloid Leukaemia -CML- in chronic phase (CP)
•2.Failure to achieve at least a Major Cytogenetic Response (MCyR) after a minimum of 18 months of TKIs treatment
•3.Inability to tolerate 3 months of uninterrupted full dose TKIs therapy due to hematological toxicity
•4.A minimum of three treatment interruptions due to hematological toxicity Availability of a HLA-identical related donor (Matched Related Donor, MRD)
•5.Availability of unrelated donor (Matched Unrelated Donor, MUD) satisfying the criteria of a 10/10 antigen match at HLA-A, -B, -C and - DRB1, -DQB1 at high resolution typing, or 9/10 with a permissive – DP disparity according to Fleischhauer model (Crocchiolo et al, Blood 2009)
•6.Target graft size (bone marrow):
•7.bone marrow: > 3 x 106 CD34+ cells/kg BW recipient
•or > 3 x 108 nucleated cells/kg BW
•8.Karnofsky Index = 80 %
•9.Age =18 and =70 years
•10.Adequate contraception in female patients of child-bearing
•11.Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 14
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•1.Secondary malignancies
•2.A hematopoietic cell transplantation-specific comorbidity index (Sorror et al Appendix C) > 4
•3.Known and manifested malignant involvement of the CNS
•4.Active infectious disease
•5.Active HIV, HBV or HCV infection
•6.Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit)
•7.Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit).
•8.Pleural effusion or ascites > 1.0 L
•9.Pregnancy or lactation
•10.Known hypersensitivity to Busilvex and/or fludarabine
•11Non-co-operative behaviour or non-compliance
•12 Psychiatric diseases or conditions that might impair the ability to give informed consent

发起方

IVERSITà DEGLI STUDI MILANO BICOCCA